On 17 May 2024, the Official Journal of the European Union published Commission Regulation (EU) 2024/1328 amending REACH regarding the use of octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane…
MDR: 49th Notified Body on NANDO!
The NANDO database now includes the first Austrian MDR Notified Body, which brings the total number of notified bodies under Regulation (EU) 2017/745 on medical…
MDR: 48th Notified Body on NANDO!
The NANDO database lists a new Notified Body under the MDR, which is the second NB in 2 days! Kiwa Belgelendirme Hizmetleri A.Ş. is overall…
MDR: 47th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! MTIC InterCert S.r.l. is the 47th EU Notified Body notified under Regulation (EU) 2017/745…
Parliament votes in favor of IVDR legacy extension and EUDAMED mandatory use
On 25 April 2024, the European Parliament voted in favour of the Proposal to extend the transitional provisions for IVDR legacy devices, introduce a gradual…
MDR: 46th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! AFNOR Certification is the 46th EU Notified Body notified under Regulation (EU) 2017/745 on…
New MDCG Guidance on content of the Investigator’s Brochure for clinical investigations under MDR
Recently the MDCG (Medical Device Coordination Group) published a guidance on the content of the Investigator’s Brochure for clinical investigations of medical devices (MDCG 2024-5).…
New MDCG guidance on safety reporting in IVDs performance study
The MDCG (Medical Device Coordination Group) just published a new guidance document on safety reporting in performance studies of in-vitro diagnostic medical devices: MDCG 2024-4.…
MDR: 45th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! TÜV SÜD Danmark is the 45th EU Notified Body notified under Regulation (EU) 2017/745…
2024: Which MDCG guidance can we expect?
The European Commission has released the updated document on the ongoing work of the MDCG and its subgroups. We present you below some of the…